Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Siemens Healthcare Diagnostics Limited ASI 19-04 Atellica CH 930 Analyzer

   The purpose of this communication is to inform you of issues with the Atellica CH 930 Analyzer listed in Table 1 above, installed ...

   Waarschuwing | 04-09-2019

2. Roche Diagnostics GmbH IO-0000166 (SBN-CPS-2019-019) IGG-2 (Tina-quant IgG Gen.2)

   As CSF samples have lower concentrations than serum samples, due to carry over, a CSF sample might yield discrepant higher ...

   Waarschuwing | 03-09-2019

3. Siemens Healthcare Diagnostics Inc. POC 19-021 Atellica UAS 800 Analyzer

   Siemens Healthcare Diagnostics has confirmed that a communication error could be generated on the system application software ...

   Waarschuwing | 01-09-2019

4. Randox Laboratories, REC407, Rheumatoid Factor Standard, Liquid Protein Calibra

   Randox is conducting a Device Modification for Rheumatoid Factor Standard and Liquid Protein Calibrator for the lots specified in ...

   Waarschuwing | 30-08-2019

5. Philips Electronics, CQ70126, LABOSYS

   Philips heeft een fout geconstateerd bij de rapportage van antibiotica uitslagen voor de microbiologie.

   Waarschuwing | 28-08-2019

6. Roche Diagnostics GmbH CN-428741 (SBN-CPS-2019-014) ALB2 (Albumin Gen.2)BILT3 (Bilirubin Total Gen.3)

   Roche has received a number of complaints about Albumin Gen.2 (ALB2) reagent lot 33962301 and Bilirubin Total Gen.3 (BILT3) ...

   Waarschuwing | 28-08-2019

7. BIOMERIEUX SA FSCA 4459 VIDAS FT4

   VIDAS® FT4 is an automated quantitative enzyme immunoassay for use with the instruments of the VIDAS® family, to determine free ...

   Waarschuwing | 23-08-2019

8. Diamed, FSCA 005-19, Immunohaematology/blood bank analyser IVD, automat

   An anomaly of the instrument has been observed when all the conditions described below are met:..

   Waarschuwing | 21-08-2019

9. Roche Diagnostics GmbH IO-0000165 SFTR (Tina-quant Soluble Transferrin Receptor)

   During the feasibility study for the new Tina-quant Soluble Transferrin Receptor assay generation, it was observed that the ...

   Waarschuwing | 15-08-2019

10. Philips Electronics Nederland B.V. PBE-190801-001, LABOSYS

    Philips heeft een fout geconstateerd in de electronische (HL7 2.4 ORU) rapportage van uitslagen voor LABOSYS indien deze volgens ...

    Waarschuwing | 13-08-2019